drugset / Trial / NCT07498387

Management of Catatonic Features in Adolescents With Profound Autism

NCT07498387

Active not recruiting 30 enrolled Tanta University
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn if benzodiazepines and ECT can treat Catatonic features in Adolescents with Autistic spectrum disorder, it will also learn about Safety and efficacy of benzodiazepines and ECT. the main questions it aim to answer is if adolescents with profound Autism presenting with catatonic features will show significant improvement on treatment with either benzodiazepines or ECT with no major side effects. it is an open label pilot study whose participants diagnosed with profound autism presenting with catatonia will receive loading midazolam then maintenance clonazepam daily / ECT sets will be followed up every 2 weeks in 1st month then once / month for next 2 months, observation of symptom improvement will be tracked. Clinical outcomes will be assessed using the Pediatric Catatonia Rating Scale as the primary outcome measure and the Aberrant Behavior Checklist as a secondary outcome measure. Participants will be followed for three months to evaluate treatment response and safety.

Timeline

Start
2026-01-01
Primary completion
2026-08
Completion
2026-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Clonazepam Small molecule 2 mg Oral
Subject Midazolam Small molecule 0.2 mg/kg Intranasal
Subject Midazolam Small molecule 0.3 mg/kg Intranasal